| CTRI Number |
CTRI/2018/02/011743 [Registered on: 07/02/2018] Trial Registered Prospectively |
| Last Modified On: |
07/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Nagpheni juice in anemia |
|
Scientific Title of Study
|
Experimental and clinical studies on Nagapheni (Opuntia elatior Mill.), an anukta dravya (extra-pharmacopoeial drug), with special reference to its Haematinic activity |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof R N Acharya |
| Designation |
Professor and HOD Dravya guna |
| Affiliation |
|
| Address |
Dept of Dravya guna
IPGT and RA
Gujarat Ayurved university
Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
2882552014 |
| Fax |
|
| Email |
rnacharya@ayurveduniversity.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof R N Acharya |
| Designation |
Professor and HOD Dravya guna |
| Affiliation |
IPGT and RA Gujarat Ayurved university |
| Address |
Dept of Dravya guna
IPGT and RA
Gujarat Ayurved university
Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
2882552014 |
| Fax |
02882676856 |
| Email |
rnacharya@ayurveduniversity.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof R N Acharya |
| Designation |
Professor and HOD Dravya guna |
| Affiliation |
IPGT and RA Gujarat Ayurved university |
| Address |
Dept of Dravya guna
IPGT and RA
Gujarat Ayurved university
Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
2882552014 |
| Fax |
02882676856 |
| Email |
rnacharya@ayurveduniversity.com |
|
|
Source of Monetary or Material Support
|
| Ministry of AYUSH, New Delhi |
|
|
Primary Sponsor
|
| Name |
Ministry of AYUSH |
| Address |
Ministry of AYUSH
New Delhi |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof R N Acharya |
IPGTRA Hospital |
IPGTRA Hospital
Gujarat Ayurved university campus, near Police B-division Jamnagar
Jamnagar
GUJARAT |
9924585855
02882552014
rnacharya@ayurveduniversity.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGTRA IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients between age of 18-60 years
Male and female patients diagnosed cases of Pandu (Iron deficiency anaemia)
8-10 g% of Hb% or reduced RBC count
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nagpheni Opuntia elatior Mill juice |
Nagpheni juice 20 ml two times before meal for 60 days |
| Comparator Agent |
Tab. Punarnava mandura |
Tab Punarnava mandura 2gm
two times a day before meal for 60 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between age of 18-70 years
2. Patients of both gender
3. Diagnosed cases of Pandu (iron deficiency anaemia)
4. Patients having Hb% in between 8-10 g
5. Patients with reduced RBC count
|
|
| ExclusionCriteria |
| Details |
1. Age less than 18 years and more than 70 years.
2. Pregnant women and lactating mothers.
3. Cases of Chronic Renal (CRF)/
4. Cases of Chronic Hepatic diseases, Cardiac diseases(CCF) and Cancer
5. Any continuing blood loss e.g., Hematemesis, Melaena, Bleeding piles etc. having Hb% less than 7g%
6. Patients consuming alcohol
7. Patients those are on steroids treatment
8. Patients with treatment of any haematinic drug(Ayurveda/modern) within last two months
9. Minimum wash out period of two months if patients are under previous therapy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to increase hemoglobin level |
To attend 10gm % of Haemoglobinlevel after 2 month of trial drug Opuntia elatior Mill. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to improve QOL of patient |
To increase serum ferritin level
Improvement of the quality of life of the patients (to be assessed as per WHO criteria)
Development of a new drug for easy palatable administration.
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
09/02/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The patients of age 18 to 70 years anemia with 8-10 g% of Hb% will be enrolled in the study and randommly allocated in two groups. In one group (n=50) Hatala juice 20 ml two times before meal will given orally for 60 days. In another group (n=50) Tab. Punarnava mandur 2 gm two times with plain water two time s a day for 60 days will given orally before meal. The result will be assessed on the basis of subjective and objective parameter (Hb%). Conclusion will be drawn on the basis of final result |